510(k) · Cleared
ClearedOnli Intermittent Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister Incorporated · GBM Catheter, Urethral
Cleared on Jan 26, 2017 as substantially equivalent to K141642 (Hollister Incorporated, 2014) after a 73-day review. Its family tree reaches back 6 generations to 1991. 3 later devices descend from it.
- Decided
- Jan 26, 2017
- Review
- 73 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K910022 (1991). 14 ancestors in all, the oldest K896750 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 5 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 4 generations backK023254 SpeedicathColoplast Corp. · 2003
- 3 generations backK090960 Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142…Hollister, Inc. · 2009
- 2 generations backK110862 Vapro Plus Intermittent CatheterHollister Incorporated · 2011
- 1 generation backK141642 Vapro Intermittent CatheterHollister Incorporated · 2014
- This deviceK163179 Onli Intermittent CatheterHollister Incorporated · 2017
- Descendant · cites it directly · 1 of its ownK191633 Infyna ChicHollister Incorporated · 2019
- Descendant · 2 generations on · 0 of its ownK213575 Female IC (Not Finalized)Hollister Incorporated · 2022
- Descendant · cites it directly · 0 of its ownK211436 Intermittent Catheter (Not Finalized)Hollister Incorporated · 2022 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −5 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −4 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| −3 | K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064… | Hollister, Inc. | 2009 | — |
| −2 | K110862 | Vapro Plus Intermittent Catheter | Hollister Incorporated | 2011 | — |
| −1 | K141642 | Vapro Intermittent Catheter | Hollister Incorporated | 2014 | — |
| 0 (this device) | K163179 | Onli Intermittent Catheter | Hollister Incorporated | 2017 | — |
| +1 | K191633 | Infyna Chic | Hollister Incorporated | 2019 | — |
| +2 | K213575 | Female IC (Not Finalized) | Hollister Incorporated | 2022 | — |
| +1 | K211436 | Intermittent Catheter (Not Finalized) | Hollister Incorporated | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GBM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GBM device
- #1 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141642 | Vapro Intermittent CatheterSummary page 4…ical catheter and accessories Device Class: Class II per 21 CFR 876.5130 Product Code: GBM Predicate Device: VaPro intermittent catheter, K141642 Device Description: The Onli intermittent catheter is a single use catheter to be used as a means… | 2014 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K191633 (Hollister Incorporated, 2019) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K141642.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GBM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GBM
230in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GBM
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBM
311in 2025
MAUDE reports naming product code GBM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 5 |
| 2008 | 0 | — | 5 | 18 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 2 | — | 1 | 46 |
| 2012 | 3 | 139 | 0 | 32 |
| 2013 | 0 | — | 0 | 41 |
| 2014 | 1 | — | 0 | 19 |
| 2015 | 5 | 76 | 0 | 21 |
| 2016 | 3 | 112 | 0 | 49 |
| 2017 | 2 | — | 0 | 59 |
| 2018 | 6 | 93 | 0 | 82 |
| 2019 | 7 | 121 | 0 | 148 |
| 2020 | 6 | 230 | 0 | 144 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 2 | — | 0 | 283 |
| 2023 | 0 | — | 1 (1) | 202 |
| 2024 | 0 | — | 0 | 468 |
| 2025 | 1 | — | 1 | 311 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Onli intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female, and pediatric patients who need to drain urine from the bladder
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163179 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163179: Onli Intermittent Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163179
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026